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    Celex 32023R1194 en TXT

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    nikito
    This document amends Implementing Regulation (EU) 2022/2346 to extend certain transitional provisions for medical devices. Specifically, it: 1) Extends the transitional periods for products where clinical investigations are performed or where a notified body is involved in conformity assessments. 2) Allows products covered by an expired certificate issued under Directive 93/42/EEC to continue being placed on the market if they meet certain conditions, in alignment with amendments made by Regulation (EU) 2023/607. 3) Applies the amendments from 22 June 2023 to ensure economic operators can benefit directly and ensure continuity for products previously covered.

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    Celex 32023R1194 en TXT

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    nikito
    21 views3 pages
    This document amends Implementing Regulation (EU) 2022/2346 to extend certain transitional provisions for medical devices. Specifically, it: 1) Extends the transitional periods for products where clinical investigations are performed or where a notified body is involved in conformity assessments. 2) Allows products covered by an expired certificate issued under Directive 93/42/EEC to continue being placed on the market if they meet certain conditions, in alignment with amendments made by Regulation (EU) 2023/607. 3) Applies the amendments from 22 June 2023 to ensure economic operators can benefit directly and ensure continuity for products previously covered.

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    This document amends Implementing Regulation (EU) 2022/2346 to extend certain transitional provisions for medical devices. Specifically, it: 1) Extends the transitional periods for products where clinical investigations are performed or where a notified body is involved in conformity assessments. 2) Allows products covered by an expired certificate issued under Directive 93/42/EEC to continue being placed on the market if they meet certain conditions, in alignment with amendments made by Regulation (EU) 2023/607. 3) Applies the amendments from 22 June 2023 to ensure economic operators can benefit directly and ensure continuity for products previously covered.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    21 views3 pages

    Celex 32023R1194 en TXT

    Uploaded by

    nikito
    This document amends Implementing Regulation (EU) 2022/2346 to extend certain transitional provisions for medical devices. Specifically, it: 1) Extends the transitional periods for products where clinical investigations are performed or where a notified body is involved in conformity assessments. 2) Allows products covered by an expired certificate issued under Directive 93/42/EEC to continue being placed on the market if they meet certain conditions, in alignment with amendments made by Regulation (EU) 2023/607. 3) Applies the amendments from 22 June 2023 to ensure economic operators can benefit directly and ensure continuity for products previously covered.

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    L 158/62 EN Official Journal of the European Union 21.6.

    2023

    COMMISSION IMPLEMENTING REGULATION (EU) 2023/1194


    of 20 June 2023
    amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain
    products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of
    the European Parliament and of the Council

    (Text with EEA relevance)

    THE EUROPEAN COMMISSION,

    Having regard to the Treaty on the Functioning of the European Union,

    Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical
    devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing
    Council Directives 90/385/EEC and 93/42/EEC (1), and in particular Article 1(2), in conjunction with Article 9(1), thereof,

    Whereas:

    (1) Article 2(1) and (2) of Commission Implementing Regulation (EU) 2022/2346 (2) set out transitional provisions for
    products for which clinical investigations are performed or for which a notified body has to be involved in the
    conformity assessment. Article 2(3) of that Implementing Regulation also sets out specific transitional provisions
    for products covered by a certificate issued by a notified body in accordance with Council Directive 93/42/EEC (3).

    (2) Regulation (EU) 2023/607 of the European Parliament and of the Council (4) extended the transitional period
    provided for in Regulation (EU) 2017/745 for certain medical devices, including those which are covered by a
    certificate issued by a notified body in accordance with Directive 93/42/EEC that is valid, until 31 December 2027
    or 31 December 2028, depending on the risk class of the device.

    (3) To ensure consistency and provide legal certainty for economic operators, the transitional provisions set out in
    Implementing Regulation (EU) 2022/2346 for products covered by a certificate issued by a notified body in
    accordance with Directive 93/42/EEC should be aligned with those set out in Regulation (EU) 2017/745, as
    amended by Regulation (EU) 2023/607.

    (4) Products covered by a certificate issued by a notified body in accordance with Directive 93/42/EEC benefit from a
    specific transitional provision laid down in Implementing Regulation (EU) 2022/2346. The provision has been
    applicable since 22 December 2022 and allows those products to be placed on the market or put into service
    subject to certain conditions, even if the certificate has expired. To the extent that such products do not benefit
    from the extended transitional provisions provided for in Regulation (EU) 2017/745, as amended by Regulation
    (EU) 2023/607, the possibility to continue to place them on the market or put them into service even if the
    certificate issued by a notified body in accordance with Directive 93/42/EEC has expired, should be provided as a
    specific transitional provision in this Regulation. To ensure consistency, applicable conditions set out in Article 120
    of Regulation (EU) 2017/745, as amended by Regulation (EU) 2023/607, should be met.

    (1) OJ L 117, 5.5.2017, p. 1.


    (2) Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of
    products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of
    the Council on medical devices (OJ L 311, 2.12.2022, p. 60).
    (3) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).
    (4) Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745
    and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices (OJ L 80,
    20.3.2023, p. 24).
    21.6.2023 EN Official Journal of the European Union L 158/63

    (5) In order to reduce as much as possible the overlap with conformity assessments of medical devices covered by a
    certificate issued by a notified body in accordance with Directive 93/42/EEC and thereby reduce the burden on
    notified bodies and the risk of shortages of devices, the transitional provisions in Implementing Regulation
    (EU) 2022/2346 for products for which clinical investigations are performed or for which a notified body has to be
    involved in the conformity assessment procedure should be extended by 18 and 30 months, respectively.

    (6) The transitional provisions in Implementing Regulation (EU) 2022/2346 for products for which clinical
    investigations are performed or for which a notified body has to be involved in the conformity assessment
    procedure apply from 22 June 2023. In order to ensure that those products can benefit directly from the extended
    transitional provisions, the relevant provisions of this Regulation should apply from the same date. Products
    covered by a certificate issued by a notified body in accordance with Directive 93/42/EEC have benefitted from the
    transitional provisions set out in Implementing Regulation (EU) 2022/2346 from 22 December 2022. In order to
    ensure that those products can smoothly benefit from the extended transitional provisions and considering that the
    specific conditions set out in this Regulation ensure continuity with those previously applicable, the relevant
    provision of this Regulation should also apply from 22 June 2023. Consequently, the former provision setting out
    the applicability from 22 December 2022 should be deleted from Implementing Regulation (EU) 2022/2346 from
    the date of application of the amended provision set out in this Regulation.

    (7) To ensure that economic operators can rapidly access and implement the extended transitional provisions
    established by this Regulation, it should enter into force from the day of its publication in the Official Journal of the
    European Union.

    (8) Implementing Regulation (EU) 2022/2346 should therefore be amended accordingly.

    (9) The Medical Device Coordination Group has been consulted.

    (10) The measures provided for in this Regulation are in accordance with the opinion of the Committee on Medical
    Devices,

    HAS ADOPTED THIS REGULATION:

    Article 1

    Implementing Regulation (EU) 2022/2346 is amended as follows:


    (1) Article 2 is amended as follows:
    (a) paragraph 1 is amended as follows:
    (i) in the first subparagraph, the date ‘22 June 2028’ is replaced by ‘31 December 2029’;
    (ii) in the third subparagraph, the date ‘22 June 2026’ is replaced by ‘31 December 2027’;
    (iii) the fourth subparagraph is replaced by the following:
    ‘By way of derogation from the first subparagraph, from 1 January 2028 until 31 December 2029, a product
    that meets the conditions laid down in that subparagraph may only be placed on the market or put into
    service, if a written agreement for the performance of the conformity assessment has been signed by the
    notified body and the manufacturer in accordance with Section 4.3, second subparagraph, of Annex VII to
    Regulation (EU) 2017/745.’;
    (b) paragraph 2 is amended as follows:
    (i) in the first subparagraph, the date ‘22 June 2025’ is replaced by ‘31 December 2028’;
    (ii) the second subparagraph is replaced by the following:
    ‘By way of derogation from the first subparagraph, from 1 January 2027 until 31 December 2028, a product
    that meets the conditions laid down in that subparagraph may only be placed on the market or put into
    service, if a written agreement for the performance of the conformity assessment has been signed by the
    notified body and the manufacturer in accordance with Section 4.3, second subparagraph, of Annex VII to
    Regulation (EU) 2017/745.’;
    L 158/64 EN Official Journal of the European Union 21.6.2023

    (c) paragraph 3 is replaced by the following:


    ‘3. A product which was covered by a certificate issued by a notified body in accordance with
    Directive 93/42/EEC that expired after 26 May 2021 and before 20 March 2023, and for which the conditions
    laid down in Article 120(2), second subparagraph, point (a) or (b), of Regulation (EU) 2017/745 are not met, may
    be placed on the market or put into service until the dates laid down in Article 120(3a) of Regulation
    (EU) 2017/745, also after the expiry of the certificate, provided that the conditions set out in Article 120 (3c), (3d)
    and (3e), of Regulation (EU) 2017/745 are met.’;
    (2) in Article 3(2), the second sentence is deleted.

    Article 2

    This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

    It shall apply from 22 June 2023.

    This Regulation shall be binding in its entirety and directly applicable in all Member States.

    Done at Brussels, 20 June 2023.

    For the Commission


    The President
    Ursula VON DER LEYEN

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